Carvedilol (drug) With or Without Simvastatin (drug) in Patients With Liver disease
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Cirrhosis with portal hypertensionHealth Condition 2: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2018/02/011704
- Lead Sponsor
- Institute of liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
1)All patients of chronic liver disease with large esophageal varices.
2)Age more than and equal to 18 years.
Exclusion Criteria
1)Patients of chronic liver disease with history of upper Gastro Intestinal bleed.
2)Patients of acute on chronic liver failure
3)Thrombosis of splenoportal axis
4)Hepatocellular carcinoma
5)Patients who were on primary variceal ligation sessions as prophylaxis
6)Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).
7)Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}.
8)Failure to give consent for inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total number of patients who will be Responders. <br/ ><br> <br/ ><br>Responders are defined as(Absolute value of HVPG12 mm Hg or HVPGâ?¥20% reduction)Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method Total number of patients develop PHG (Portal Hypertensive Gastropathy)Timepoint: 3 months;Improvement in the CTP (Child-Turcotte-Pugh score) score.Timepoint: 3 months;Improvement in the MELD (Model for End Stage liver Disease) score.Timepoint: 3 months;Total number of patients develop adverse Events of the study drugTimepoint: 3 months;Total number of patients develop esophageal variceal bleedTimepoint: 3 months;Total number of patients develop Gastric Varices.Timepoint: 3 months;Total number of patients develop GAVE (Gastric Antral Vascular Ectasia)Timepoint: 3 months